The IRB retains the sole and final authority at Trinity College for the approval of applications to conduct research involving human subjects.
The IRB review process applies to research conducted by faculty, students, staff, visiting scholars and others whether conducted on Trinity College premises, at off-campus sites, or under subcontracts to other entities.
The review requirement applies to all "human subjects" research conducted under the auspices of Trinity College, regardless of funding source, sponsored and unsponsored.
The IRB is responsible for ensuring that all approved research complies with the letter and spirit of the human subject protection regulations as well as the ethical principles stated in The Belmont Report
: respect for persons, beneficence, and justice.
The IRB examines research protocols in terms of procedures to recruit human subjects, proposed remuneration if any, and adequacy of the informed consent process. In addition, the IRB evaluates the risks and potential benefits to participants as outlined in each protocol. The broad purpose of this review is to help ensure that investigators recruit subjects in an equitable manner that is non-coercive, that subjects are fully informed about the risks and benefits entailed in the research, and that subjects are not exposed to disproportionate risks.
- 3.1 Risks and Benefits
- 3.2 Minimal Risk Defined
- 3.3 Equitable Selection of Research Participants
- 3.4 Identification of Participants and Confidentiality
- 3.5 Informed Consent
- 3.6 Additional Monitoring and Safeguards
- 3.7 Research Involving Vulnerable Populations
- 3.8 Students and Research Course Credits
Section 3.1 Risks and Benefits
The IRB will assess whether the risks to participants are reasonable in relation to the anticipated benefits to the participants or to society. In particular, the IRB reviews proposed studies to ensure that the risks are minimized to the greatest extent possible and to ensure that the benefits of research participation are maximized.
The IRB will consider the scientific merit of the study design, since it would be unethical to place human subjects at risk with a study where methodological procedures are flawed such that little or no reliable information will be obtained.
The IRB also considers any possible benefits a subject may derive from participation in research, and/or the benefits of new knowledge that may justify asking a person to undertake the risks of the study. Payments or other incentives for participation in research are not considered, and should not be described as, benefits to subjects.
Risk means the probability of harm, whether physical, psychological, social, legal or economic. Both the probability and magnitude of possible harm may vary from minimal risk to greater than minimal. Risks also include immediate risks of study participation, risks of breach of confidentiality, inadvertent disclosures, and risks of long-term effects. Risks should be minimized by screening out prospective participants at undue risk, proper monitoring of procedures once in place, and adequate protection of individual privacy and confidentiality. Risks to subjects are minimized by using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and, whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes. A benefit is a valued or desired outcome or an advantage. Benefits of research may accrue directly to the individual participating in the research, or to society as a whole, as is often the case in social, behavioral, and educational research.
3.2 Minimal Risk Defined
Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
Guidance: The IRB considers minimal risk studies as comparable to the following examples:
- tests and measures of mental status or memory functioning outside of a clinical setting;
- standardized IQ tests;
- personality inventories;
- consumer preference surveys;
Other routine, non-sensitive, information, such as data gathered for educational or employment purposes where there is an expectation of standardized tests or routine examinations.
Greater than minimal risk studies may include research procedures that employ:
- covert observations in settings where privacy is expected,
- collection of data that could result in embarrassment or other personal harms due to a breach of confidentiality,
- infliction of pain or physical discomfort,
- use of medical records or protected health information, or
the enrollment of participants with impairments, disabilities or psychological disorders.
3.3 Equitable Selection of Research Participants
The selection of participants should be equitable and free of coercion. The IRB will consider the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.
Guidance: Where appropriate, investigators should indicate in their protocol how they will avoid even the appearance of coercion in the recruitment of participants. They should also detail any extra precautions that will be taken to safeguard the rights and welfare of vulnerable populations.
3.4 Identification of Participants and Confidentiality
The IRB will scrutinize the methods for prospective identification and contact of participants. This includes a review of the means proposed by the investigator for insuring participant privacy and confidentiality.
The IRB will also examine the importance of the research, the sensitivity of any information sought from the participants, and the special procedures devised by the investigator for protecting any private or personal information.
3.5 Informed Consent
The IRB will review the process described by the investigator for obtaining informed consent including when, where and how consent is obtained and any provisions for the ongoing consent of participants. (See section 5.0 of this manual for the detailed requirements of the informed consent process, methods for documentation, and any requests for waivers or alterations of written informed consent.)
3.6 Additional Monitoring and Safeguards
The IRB will assess whether a project requires more than annual review and whether a project needs any additional monitoring procedures to ensure the safety of the participants. Both of these determinations generally will be based on the degree of risk in the study. Appropriate safeguards could include monitoring of the consent process, observation of the research procedures, or review of research related results.
When vulnerable subjects are included in a project, the IRB will determine whether any additional safeguards are appropriate to protect their rights and welfare, and if so, whether these procedures have been included.
3.7 Research Involving Vulnerable Populations
Subparts of the HHS regulations in (45 CFR 46
) require additional protections for the following categories of subjects:
- Pregnant Women, Human Fetuses and Neonates Involved in Research (Subpart B)
- Biomedical and Behavioral Research Involving Prisoners as Subjects (Subpart C); and
- Children Involved as Subjects in Research (Subpart D)
Research investigators should consult 45 CFR 46
, Subparts B, C, and D for descriptions of these additional requirements. In addition to the categories identified in Subparts B, C, and D, vulnerable populations include persons with diminished capacity to freely give informed consent, due to such factors as limited education, lack of fluency in English or other pertinent languages, or limited mental capacity.
3.8 Students and Research Course Credits
Trinity College students may be recruited for participation in research studies or experiments to include the prospect of earning research course credits or extra credit points for grades. However, the investigator or course instructor proposing these studies and credits must demonstrate to the IRB that the students in the subject pool are not being coerced and that their consent will be freely given. Care should be taken to eliminate any undue influence of faculty so that participation is not a course requirement without the possibility of other alternatives.
In all cases there must be an educational value or benefit to students explicitly described in the protocol and in the consent form, along with measures to protect student autonomy and confidentiality. Students must be provided with choices and options in order to obtain the equivalent course credits or grade incentives.
Examples of alternatives include:
- attendance at a research seminar;
- writing a brief research abstract or journal article report; or
- other assignments with educational value
Alternative activities should be comparable to research participation in terms of time, effort and convenience. If evaluated, these projects should be graded on a "credit/no credit" scale.
Investigators should avoid any inference that volunteering to join a study will place students in good favor with the faculty in the course in terms of grading, recommendations, or future employment. In the close environment of the college, special attention should be given to the handling of data to minimize any risks of inadvertent breaches of confidentiality. For example, students should not be invited to participate in research that could reveal confidential or private information to their peers and mentors or that may embarrass or compromise the individual student.